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Alessia Frabetti

Medical Devices Business Sector Manager, Kiwa Cermet Italia

BD in Biology addressing physiopathology topics and PhD in Architectural technology working on chemical and mechanical healthcare material property, with 20 years of extensive experience in medical device, pharma and healthcare Organizations related to R&D, production & validation, risk evaluation, testing and conformity assessment activities. From 2014 I’m Medical Device Division Director in Kiwa Cermet Italia (NB 0476) an International Company providing globally Testing, Inspection and Certification services, with the responsibility to drive the medical certification business of the Notified Body 0476 managing the P&L and leading a team of more than 40 experts. Moreover, as a qualified auditor and product assessor I also play a crucial role carried out conformity assessment activities especially on substances-based, non-active implantable device. Being Kiwa one of the members of Team NB, I’m also involved in working groups and task force with the aim to prepare position paper.


Situation with Notified Bodies

Location Darwin room Start / end time 3:00 pm to 4:00 pm

Five Notified Bodies will be represented during this session. They are all designated under MDR and for a few also under the IVDR.

Through a panel discussion, we will tackle current challenges both for the manufacturers and for them, in an interactive manner where the audience can also ask questions.

This session will also be the opportunity to get their feedback on submissions and areas of improvements in order to ensure a smoother review process.